Specialist Process Engineering (MS&T) – Upstream or Downstream

About the role

Our Dublin biotech facility, operational since 2021, is expanding its team of specialists in process engineering. The Specialist MS&T will join either the upstream or downstream team based on experience, supporting process qualification, equipment design, technology transfer and commercialization while ensuring compliance with cGMP and company policies.

Key responsibilities

• Ensure compliance with global policies, regulatory requirements and cGMP in daily activities.
• Support execution of development and PPQ batches, change control, investigations, root‑cause analysis and CAPA implementation.
• Participate in internal and external audits and drive continuous improvement using Lean Six Sigma tools.
• Design, construct and qualify upstream/downstream equipment and lead NPI/technology transfer projects.
• Interpret commercial process monitoring data (PPA, CPV, SPC, MVDA) to improve yield and robustness.
• Author and review batch documentation, technical reports and regulatory submissions.

Required profile

• Degree in (Bio) Chemistry, Process Technology, Biotechnology, Engineering or comparable field.
• Experience with upstream cell culture and/or downstream purification of biologics.
• Experience with technology transfer, regulatory filing and commercial drug substance manufacturing is preferred.
• Familiarity with change management, deviations and CAPA processes is desirable.

Required skills

• CAPA investigations
• Cell culture techniques
• Manufacturing operations
• Process control
• Six Sigma methodology
• Technology transfer